January 8, 2018 News by Patricia Silva, PhD MMJ Files Patent on Part-cannabinoid and Part-non-cannabinoid Treatment for MS MMJ International HoldingsĀ is seeking a patent for a part-cannabinoid and part-non-cannabinoid treatment forĀ multiple sclerosisĀ and other diseases. The company said in aĀ news releaseĀ that it filed the patent request ahead of Phase 2 clinical trials of the formulation. Ā The therapy was developed by MMJ Bioscience, anĀ affiliate of MMJ International…
January 4, 2018 News by Patricia Silva, PhD FDA Warns of Risks Linked to Gadolinium-based Contrast Agents Used in MRI Scans The U.S. Food and Drug Administration (FDA) has updated aĀ safety bulletinĀ about gadolinium-based contrast agents (GBCAs), after studies raised new concerns about them. Doctors often use GBCAs to diagnoseĀ multiple sclerosis (MS),Ā monitor disease activity and verify the effectiveness of MS therapies.Ā Gadolinium is a metal ion, or electrically charged molecule, that…
December 20, 2017 News by Alice MelĆ£o, MSc FDA Gives Fingolimod a Breakthrough Therapy Designation for Relapsing MS in Children The U.S. Food and Drug Administration has givenĀ fingolimodĀ a Breakthrough Therapy designation as a treatment for children 10 years and older and adolescents with relapsing multiple sclerosis. NovartisĀ is marketing it in the United States under the brand name GilenyaĀ for adults with relapsing MS. It has yet to approved…
December 15, 2017 Columns by Ed Tobias Using Biotin? It Could Impact Your Lab Results Be careful if you’re using high-dose biotin (vitamin B7). The biotin in your blood could lead to some false readings when you have that blood tested. The level of concern about this is high enough to warrant aĀ warning from the U.S. Food and Drug Administration. High doses of biotin…
November 21, 2017 News by Larry Luxner Rare Disease Patient Groups Unite to Preserve Orphan Drug Tax Credit in US The National Organization for Rare Disorders (NORD) says itās ādisappointed and dismayedā after the House of Representatives voted 227-205 last week to repeal the Orphan Drug Tax Credit as part of a U.S. tax reform package. A similar package before the Senate Finance Committee does not repeal the credit…
November 15, 2017 News by Patricia Inacio, PhD Ozanimod Superior to Avonex in Treating Relapsing MS in Phase 3 Trials, Celgene Reports Celgene released the results of two Phase 3 trials showing that patients with relapsing multiple sclerosis (MS) who were treated withĀ ozanimod had lowerĀ relapse rates andĀ fewer MRI brain lesions compared to those given a current first-line therapy, AvonexĀ (interferon Ī²-1a). These results will be used to support a request…
October 5, 2017 News by Patricia Silva, PhD FDA Approves Mylanās Generic Copaxone, Introducing First Generic High-Dose Version The U.S. Food and Drug Administration has approved both lower and higher doses ofĀ Mylanās generic versions of Copaxone (glatiramer acetate) for relapsing multiple sclerosis. It is the first time the agency has authorized a higher-dose generic. Generic versions of the lower dose of 20 mg/mL ā intended for…
October 4, 2017 News by Alice MelĆ£o, MSc FDA Clears Antisense Therapeutics to Proceed with Phase 2b Trial of ATL1102 in RRMS and SPMS Patients Antisense TherapeuticsĀ announced that it is proceeding with a Phase 2b clinical trial of ATL1102,Ā its lead candidate to treat multiple sclerosis, afterĀ theĀ U.S. Food and Drug Administration (FDA) lifted a clinical hold it had placed on the company’s request ā in the form of a trial application or IND ā…
August 8, 2017 News by Patricia Silva, PhD TG Therapeutics, FDA Agree on Phase 3 Program to Evaluate Relapsing MS Therapy TG-1101 TG TherapeuticsĀ and the U.S. Food and Drug Administration (FDA) have agreed on a special protocol assessment for a Phase 3 trial program evaluating TG-1101 (ublituximab)Ā to potentially treatĀ relapsing forms of multiple sclerosis (MS). A special protocol assessment (SPA) is a procedure by which the agency officially evaluates the…
June 30, 2017 News by Patricia Silva, PhD Link Between MS Therapy Tysabri and Melanoma Possible, an Adverse Reactions Watchdog Group Says The multiple sclerosis therapy Tysabri could trigger melanoma, the Southern Network on Adverse Reactions (SONAR) has warned. Although its investigation failed to demonstrate that melanoma is more common among Tysabri-treated MS patients than in the general population, unusual features among the patients raise concerns about a possible link, the organization said. Contending that current monitoring efforts are inadequate, it suggested improvements that could generate a better understanding of the relationship between Tysabri treatment and cancer. The organization's report, published in the journal Cancer Medicine, was titled āMelanoma complicating treatment with natalizumab for multiple sclerosis: A report from the Southern Network on Adverse Reactions, also known as SONAR." SONAR is an organization that was formed in the Southern United States in 2010 to investigate adverse drug reactions that regulators might not be aware of. Its goal is to reduce the time it takes between detecting an adverse reaction and have regulators act on it. A case that a SONAR investigator came across led to the group investigating possible links between Tysabri and melanoma. A 43-year-old woman developed melanoma in her urethra, the tubing that drains urine from the bladder, after being treated with Tysabri for about two years. Melanoma is most often a skin cancer that is related to sun exposure, but the woman had no skin lesions. After extensive surgery, she relapsed and died when the cancer spread to other parts of her body. She had declined anti-cancer treatment. The case prompt SONAR to look for similar cases. Its investigators found seven studies that involved Tysabri-treated MS patients developing melanoma. In addition, they looked through the U.S. Food and Drug Administrationās Adverse Event Reporting System (FAERS) and the Tysabri Safety Surveillance Program. The surveillance program is part of the Tysabri Outcomes Unified Commitment to Health (TOUCH) database run by Tysabri's developer, Biogen, The research team found 137 cases in the FAERS database through April 1, 2014. The patients' average age was 45. Seventeen percent of the group developed tumors in locations not exposed to the sun, and nine died. The researchers said the database contained only about half the information it should have, such as tumor site, patients' family history of cancer, and earlier immunosuppressive treatment. Fifteen percent of the cases in the FAERS database were based entirely on information from the TOUCH database. Seventy-three percent were cases initially reported to FAERS but with TOUCH information added. Thirteen percent of the FAERS cases contained no additional information. Importantly, there was even less patient information in the TOUCH database than in the FAERS database. Out of eight items researchers believe a database should contain, TOUCH had information on two, on average. āThe existence of the TOUCH Safety Surveillance Program, an FDA-mandated program, did not improve melanoma reporting,ā the team wrote. This shortage of data stymies research into possible links between Tysabri treatment and melanoma, the researchers said. As an example, although the death rates in the databases were low, there was no information about survival in many cases, which could lead to flawed survival estimates. The investigation noted that patients received a wide range of Tysabri doses before they were diagnosed with melanoma. While some received only one or a few injections, others had been treated for a long time. These observations do not seem to support a link between Tysabri and melanoma, the team said. āA longer therapy duration would be expected if natalizumab caused melanoma via an immunologic pathway, unless existing nevi [lesions of the skin or mucus tissue] were already premalignant lesions,ā the researchers wrote. But other information the team found seemed to suggest a Tysabri-melanoma link. For example, the average age of melanoma patients was much lower than that reported in the National Cancer Instituteās Surveillance, Epidemiology and End Results (SEER) database. The average age in the institute's database is 63, compared with 45 in the FAERS database and 41 in cases in academic journals. In addition, many patients developed tumors in unusual places not exposed to sunlight. Finally, the low melanoma death rate in Tysabri-treated patients differed from that seen in the general population. All these factors suggest that melanoma after Tysabri treatment could differ from other types of melanoma, the researchers argued. While the molecular workings of Tysabri might promote melanoma growth, studies so far have not found a relationship between the drug and this cancer. In fact, some studies suggest that MS patients, in general, have a lower risk of melanoma than others. The team said more information on patients could give researchers a better understanding of the potential relationship between Tysabri and melanoma. The implication was that the standard of reporting in the FAERS and TOUCH databases could improve. To minimize the risk of patients who receive Tysabri developing melanoma, the researchers offered a number of suggestions for IV centers, physicians, patients, and educational programs. For instance, they suggested that all patients should have a skin examination before the start of treatment, and regular physical and skin exams while receiving Tysabri. While noting that risk of infection and the development of tumors can occur with all immunosuppressive treatments, the team said more studies are needed to explore the risk of Tysabri-treated patients developing melanoma.
June 29, 2017 Columns by Tamara Sellman The MS Alphabet: Foot Drop, Flexion, Fingolimod, and More ‘F’ Terms (Editorās note: Tamara Sellman continues her occasional series on the MS alphabet with this first of two columns about terms starting with the letter āF.ā) When it comes to multiple sclerosis, mastering an understanding of the disease means you need to mind your Ps and…
June 19, 2017 News by Alice MelĆ£o, MSc FDA Expands Dysportās Approval for Treatment of Lower Limb Spasticity in Adults The U.S. Food and Drug Administration (FDA) has expanded approval of Dysport (abobotulinumtoxinA) for treatment of spasticity in adults, a condition that affects many people in the United States, including multiple sclerosis patients. The decision was based on Dysportās supplemental Biologics License Application (sBLA)…
June 5, 2017 News by Patricia Silva, PhD FDA Approves Two Bayer Products to Help MS Patients Stay on Top of Interferon Injections The U.S. Food and Drug Administration has approved a supplemental biologics license application for two BayerĀ products that helpĀ multiple sclerosisĀ patients keep track of their injections ofĀ Betaseron (interferon beta-1b). The products are theĀ myBETAapp and theĀ Betaconnect Navigator software.Ā A biologics license application is a request for permission to market…
March 30, 2017 News by Patricia Silva, PhD Hope, But No Cheers Yet, Voiced by MS Groups in Europe and Canada Waiting on Own Ocrevus Decision American patient groupsĀ and neurologists haveĀ clearly been giving Ocrevus (ocrelizumab) plenty of attention since news of its approval landed, as a sweep of U.S. reaction to the FDA’s decision showed. But what is happening elsewhere in regard to this firstĀ treatment for both primary progressive and relapsing multiple sclerosis (MS)?…
March 29, 2017 News by Patricia Silva, PhD Excitement to Cautious Optimism ā Reactions to Approval of Ocrevus TheĀ historic approval of Ocrevus (ocrelizumab), the first-ever treatment for primary progressive multiple sclerosis (MS), set off ripples in the relatively calm waters of MS news reporting. The drug, which was also approved Tuesday as an unusually effective and safe treatment for relapsing MS, is viewed as a game-changer…
March 28, 2017 News by Patricia Silva, PhD FDA Approves Ocrevus as 1st MS Treatment for Both Relapsing and Primary Progressive Forms At long last, and for the first time in medical history, peopleĀ with both relapsing and primary progressive forms of multiple sclerosis have reason to celebrate. The U.S. Food and Drug Administration (FDA) today approved Ocrevus (ocrelizumab)Ā as a disease-modifying therapy for both forms of MS, aĀ chronic autoimmune disease.
March 17, 2017 News by Patricia Silva, PhD Ocrevus and the Hope of ‘Ending MS Forever’: Interview with MS Societyās Tim Coetzee The potential approval of Ocrevus (ocrelizumab)Ā this monthĀ supports the idea that, someday, a world free of multiple sclerosis (MS) is possible, according to Dr. Tim Coetzee, the National Multiple Sclerosis Societyās chief advocacy, services and research officer. While Coetzee ā and the society he representsĀ ā realize the potential of…
March 17, 2017 News by Patricia Silva, PhD Full Transcript of Interview with Tim Coetzee of the National MS Society Here is a transcript ofĀ Multiple Sclerosis News Today‘s interview with Dr. Tim Coetzee ā chief advocacy, services and research officer for the National Multiple Sclerosis Society ā about the importance of the U.S. Food and Drug Administration (FDA)’s awaitedĀ decisionĀ onĀ Ocrevus (ocrelizumab), and the other ongoing research. Tim…
March 1, 2017 News by Patricia Silva, PhD Acthar Gel of Dubious Value in Treating MS Despite its $34,000-Per-Vial Cost, Study Finds Medicare spent moreĀ $650 million in 2013 and 2014 on one singleĀ medication ā H.P. Acthar Gel āā that was prescribed by fewer than 1 percentĀ of clinicians to treat multiple sclerosis (MS), with questionable results. That’s the conclusion of new research byĀ Oregon Health and Science University (OSHU), which presented its…
February 28, 2017 News by Patricia Silva, PhD ‘Ocrevus Has the Potential to Change How MS Is Treated,’ Genentech’s Peter Chin Says in Interview March 28, at the latest, may be a historic date for the multiple sclerosis (MS) community ā patients, families, caregivers, researchers, and physicians alike. The U.S. Food and Drug Administration (FDA) will have its say about the marketing approval forĀ Ocrevus (ocrelizumab). The drugĀ willĀ be the first to offerĀ benefit to…
February 28, 2017 News by Patricia Silva, PhD Full Transcript of Interview with Genentech’s Medical Director, Peter Chin, on Ocrevus BelowĀ is a transcript of theĀ Multiple Sclerosis News TodayĀ interview with Dr. Peter Chin ā principal medical director at Genentech ā about the importance of the pending U.S. Food and Drug Administration (FDA) approval of a Biologics Licensing Application (BLA) for Ocrevus (ocrelizumab). An an indepth article on this interview,Ā lookingĀ Ocrevus…
January 4, 2017 Columns by Laura Kolaczkowski FDA’s Delay in Approving Ocrevus is Normal Part of the Process Long-awaited approval of the multiple sclerosis drug Ocrevus (ocrelizumab) has been delayed by the U.S. Food and Drug Administration. What had been publicized widely as a late December 2016 FDA approval hearing has now been pushed to late March 2017. The drugās manufacturer, Genentech, issued a very…
January 4, 2017 News by Joana Fernandes, PhD Top 10 Multiple Sclerosis Articles of 2016 A number ofĀ important discoveries, therapeutic developments, and events related to multiple sclerosis (MS) were reported dailyĀ by Multiple Sclerosis News Today throughout 2016. Now that the year is over, it is time to briefly review the articles that appealed most toĀ ourĀ readers. Here are the top 10 most-read articles of 2016, with…
December 22, 2016 News by Alexandra Andersson, PhD Cures Act May Speed Approval of Stem Cell Therapies for MS and Other Diseases The 21st Century Cures Act, recently signed into law by President Barack Obama, includes provisions that aim to speed up the process by whichĀ the U.S. Food and Drug Administration (FDA) reviewsĀ stem cell treatments for patients with degenerative diseases, such as multiple sclerosis, rheumatoid arthritis, and Parkinson’s disease. This act also…
December 21, 2016 News by Joana Fernandes, PhD FDA Extends Review of Ocrevus as Potential Treatment for Both Forms of MS Until March The U.S. Food and Drug Administration recently extended until the end of March its review of the Biologics License Application (BLA) forĀ Ocrevus (ocrelizumab). The application was submitted by Roche, requesting FDA approval forĀ Ocrevus as a treatment for patients with relapsing-remitting multiple sclerosis (RRMS) and ā for a first…
December 15, 2016 News by Patricia Silva, PhD FDA Accepts Bayer’s Supplemental BLA for myBETAapp and BETACONNECT Navigator for MS Patients The U.S. Food and Drug Administration (FDA) has accepted Bayerās filing of a supplemental biologics license application (sBLA) for two products designed to improve the lives of people withĀ multiple sclerosis (MS): myBETAapp and the BETACONNECT Navigator. Bayer created the BETACONNECT systemĀ to increase patient treatment compliance and improve…
October 11, 2016 News by Patricia Silva, PhD New Urinary Catheter, Designed by Quadriplegic, Approved by FDA The U.S. Food and Drug Administration (FDA) approved for marketingĀ Adapta Medicalās PerfIC Cath, an intermittent and easy-to-useĀ urinary catheter that wasĀ designed for patients with limited dexterity by a doctor who isĀ alsoĀ a quadriplegic. Urinary tract symptoms can troubleĀ peopleĀ with multiple sclerosis (MS). In fact, according to the National MS Society,…
September 26, 2016 Columns by Ed Tobias Packed House at FDA Stem Cell Hearing – Public Can Comment Through Tuesday What should be done about stem cell treatments? Are stem cells safe? Do they work? Do stem cell clinics need more regulation, or less? With some studies reporting encouraging results from using stem cells to treat a number of diseases, including multiple sclerosis, the number of clinics around…
September 26, 2016 News by Patricia Silva, PhD Change in Clinical Test Dose of Potential MS Therapy, Laquinimod, Triggers FDA Response Active BiotechĀ acknowledged inĀ an update on laquinimod, the oral small molecule being developed by Teva Pharmaceutical IndustriesĀ to treatĀ multiple sclerosis (MS) and Huntingtonās disease (HD), that the U.S. Food and Drug Administration (FDA) hasĀ rescinded the special protocol assessment given to a Phase 3 study of the treatment in…
September 22, 2016 News by Charles Moore Information on Clinical Trials to Be More Complete and Accessible Under New HHS Rules The U.S. Department of Health and Human Services (HHS) recentlyĀ announced policy changes designed to make information about clinical trials of investigational drugs, biologics and products more widelyĀ available to the public, issuing amended rulesĀ that specify the requirements for registering clinical trials and for submitting summary results to itsĀ ClinicalTrials.govĀ website. The…